A Single Arm Study to Assess the Effects of Online App Weight Loss Programs on Liver Health in Obese Adults

Noom Inc.1 site in 1 country39 target enrollmentAugust 9, 2021

ConditionsNASH Fatty Liver NAFLD Weight Loss

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: NASH
Sponsor: Noom Inc.
Enrollment: 39
Locations: 1
Primary Endpoint: Change in BMI
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this trial is to assess the effects of online app weight loss programs on liver health in obese adults.

Registry

clinicaltrials.gov

Start Date

August 9, 2021

End Date

September 12, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Noom Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female, \>18 years of age, inclusive, at Day -
•BMI of 30.00 to 49.99 kg/m2, inclusive, at Day -
•Has no plan to change smoking habits during the study period.
•Has ability to access study related online programs and apps.
•Willing to follow study instructions, as well as complete online questionnaires.
•Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigators, Sponsor and Collaborator.

Exclusion Criteria

•Self-reported presence of uncontrolled cardiac, renal, endocrine, pulmonary, biliary, pancreatic, gastrointestinal, or neurological disorders or cancer (except for non-melanoma skin cancer) that may affect the subject's ability to adhere to the study protocol and/or affect study outcomes as assessed by the PI.
•Self-reported type 1 diabetes.
•History of gastrointestinal surgery for weight reducing purposes.
•Participation in a weight loss trial or a program/service intended to alter body weight (e.g., Noom, Weight Watchers); medications, dietary supplements or products that affect weight loss, nutrient absorption, appetite and satiety; or weight loss or gain ≥10 lb (4.5 kg) within 6 mo of Day -
•Extreme dietary habits (e.g., Atkins diet, very high protein, intermittent fasting) or eating disorder.
•Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded.
•Female with prior medical diagnosis of premenstrual syndrome or premenstrual dysphoric disorder.
•Unstable use of hormonal contraceptives, anti-hypertensive medication, medications for mental or emotional disorders, or thyroid hormones within 90 d of Day -
•Exposure to any non-registered drug product within 30 d of Day -
•Recent history of (within 12 mo of Day -7) or strong potential for alcohol or substance abuse. Alcohol abuse defined as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or

Outcomes

Primary Outcomes

Change in BMI

Time Frame: baseline to day 112

BMI

Secondary Outcomes

Fibroscan - from baseline to day 112(Baseline to day 112)
Fibroscan(Baseline to day 112)
Change Weight Efficacy Life-Style (WEL) subscale scores (negative emotion, availability, social pressure, physical discomfort, and positive activities) and a global score(Baseline to day 168)
Change in RAND-36 domain scores (emotional well-being, energy/fatigue, general health, pain, physical functioning, role limitations due to emotional problems, role limitations due to physical health, and social functioning).(Baseline to day 168)